Several EU countries in addition to China are already actively using chloroquine and hydroxichloroquine to treat COVID19 patients. And I mean outside trials.
I think the anecdote on how they found out about the effectiveness of chloroquine in China is fascinating and has nothing to do with the in vitro efficiency study nor with the malaria usage but solely with the immunomodulator effect. They just noticed that there were no lupus patients infected with Covid19. And after investigating with the dermatology dept, they confirmed that indeed there were no reported lupus patients of that hospital infected with covid19.
Why do these things take slowly in US but are much faster in the EU? Even though Italy and Netherlands are already using it, no patient in US is treated with chloroquine since it's not FDA approved. Why does FDA approval matter for a brand new disease, in an emergency situation like this?
It doesn't for many known medications. But, it's a factor for new and less well understood medications.
There is "on label" and "off label" usage of drugs. Just because this existing medication is being used in the EU, or has made its way into guidelines, does not mean that it would even make it through EU approvals. It's being used "off label" if it's used for a new condition.
I've personally been treated "off label" for a condition using a drug developed and FDA approved for a serious condition that you wouldn't immediately associate with my condition. It was weird being unable to find any substantive literature on that medication and my condition, but that's the nature of uncommon conditions, or being at the edge like we are with COVID-19.
US doctors will, based on the evidence available, make their own decision on whether to follow the treatments used by their colleagues in the EU and China. They are not going to be held up by FDA approval for off-label use, but they may find things that warrant FDA review and approval because they feel the outcome is not worth the risk. The impact on the US is trailing China and EU to some degree. This buys a little time for some very smart people to do some level of analyses of what's happening elsewhere. It'd be a little different if the early waves hit here first.
So a US doctor doesn't need FDA approval to be able to prescribe something like chloroquine or Remdesivir for a COVID19 patient as long as they believe it'll be helpful to patient, did I understand it correctly?
Yes, but in practice it is rarely the situation where a doctor is making this call on their own. The hierarchy from doctor to senior leadership should be involved in decisions like this because there are many more ramifications than just one patient.
From the doctor's perspective, at minimum this is a cover-your-ass move because they don't want to get blamed for an adverse event. The administration needs to manage the risk too, and find other experts to review the situation. They may also need to manage supplies, or costs. This is really no different from the usual medical bureaucracy in the US.
One item that I'll end with is that approval processes (FDA, EU, etc.) provide no guarantees. There are many drugs that have been approved and then removed from general use based on additional experience, or long-term clinical trials. It's obviously good to do more trials and get approvals, but patients and doctors really want the best possible outcome given the situation.
The good part of the answer: Because they need to make sure the treatment doesn't kill more people than the virus does.
The bad part of the answer: Overseas testing (e.g. the testing needed for EU approvals) usually does not count for this purpose for bureaucracy reasons.
Is there no hope to expedite it in this case? Are we gonna sit and watch dozens, maybe hundreds of Americans dying of a disease that has a medication in EU and China?
Yes, there's hope to expedite it in this case. There are people working on that. The Gates foundation, for one, is funding "development" of treatments per the article[1]. "Development" includes but is not limited to getting regulatory approval as quickly as possible.
[1]- I am not affiliated with them in any way, have no specific nonpublic information, and I don't know if they are looking at this specific treatment.
If it helps, malaria is caused by a single celled parasite that isn't a bacterium. Though i don't know why that would help.
Choloroquine is also used for autoimmune disease, which also doesn't make sense. Of course none of any of this makes sense to me because i don't know anything about it.
Read the paper. They tried it on many viruses, but it had no effect, except for Hepatitis C, where it had a mild effect. Now a first small study indicates that it may be highly effective for the treatment of COVID-19. Just a try-and-error process I guess, of all available tools use the one that works best.
covid harm is due to many layers in the immune response, chloroquine might help at one layer.
it's said that many covid death are related to cytokine storm, hence why anti rhumatism drugs help, they tame the storm even if they dont touch the originating virus.
maybe, and plausibly, cquine has a similar purpose.
Drugs very rarely (especially small molecules) have an impact on only one target.
Take SSRIs (selective serotonin uptake inhibitors) used for depression. If you dig up the data, they also hit (at a lower level) acetylcholine, dopamine, histamine, and other receptors. Those off target effects are often responsible for side effects.
So chloroquine could very easily be doing something different for Coronavirus than what it does for malaria.
Anyone dismissing it as a "mild flu" is repeating seriously dangerous misinformation and the cop out of it being about "side effects for some people" is incredibly weak.
It does not matter if is mild or not for the point raised, that is a important one:
Side effects of a experimental treatment can be worse than the disease.
Even if the disease is severe. HIV is an example of a really bad problem that can be cured, but the procedure is so risky that normally it doesn't worth the try.
Cancer is a huge problem, but some people are almost insta-killed by chemoterapy for genetical reasons. There is not point into trying every snake oil available without taking in mind the side effects.
And for some groups of age, like children, yes: coronavirus currently is equivalent to a mild flu. Under 20 years old the mortality is relatively low, and for children is minimal. The coronavirus problem is not homogeneous. Is very dangerous for some people, specially when team with other previous diseases, and not so dangerous for other. The idea of treating children with a non tested treatment is ethically problematic at this moment.
For healthy young people, covid19 is a mild-ish flu. The ones in danger are their parents and grandparents, which is why Italy has been hit so hard - many young people still live with their families in cramped conditions because they cannot afford renting or much less owning their own places.
Probably it will become a huge problem in the US too, with the added difficulty that even seniors often have to work to survive and there not being a properly funded healthcare and sick leave system.
You need to add a critical “some” before “healthy young people”. For some people, it is possible to go through a whole course of coronavirus without ever showing any noticeable symptoms at all, or nothing distinguishable from a typical cold, and come out the other end immune. For example here are 2 exceptionally mild cases https://wwwnc.cdc.gov/eid/article/26/6/20-0452_article
But for some others, it is a hellishly bad experience which causes weeks of awful symptoms (e.g. only breathing via a mechanical ventilator), and for some healthy young people it even results in severe pneumonia leading to speedy death.
> The 32-year-old physician’s assistant, a non-smoker with no underlying health conditions, believes he contracted it while attending a medical conference in Times Square last weekend, saying the coronavirus spread quickly to both his lungs.
> “The virus is everything. Dirarrhea, watery eyes, shortness of breath, chest pain, you name it. High fever,” he said. “Every day is getting worse.”
As i said, the majority of people will experience mild symptoms. This poor chap clearly had a pneumonia complication. Do you have interviews with people, the majority, who presented mild symptoms or indeed none?
I had a virus and very high fever and was bedridden in early Jan. I don't recall being interviewed by the global press.
No matter how mild, the majority of cases need to be locked in a room for 2-4 weeks (because they're too flippant to be trusted to do it themselves) to prevent spreading to the other 20%+ who face permanent organ damage or worse. This isn't something that will simply kill a few hundred thousand at a cost of a couple hundred billion dollars like the flu if it's allowed to run its course through the population.
Yeah, you are so right. What realy bothers me in the way people, on HN, TV wherever, is treating numbers. You try that at one famous FAANG company and once to often, meaning a third time, and you can consider yourself lucky to just end up on a PIP.
Everbody is using the selection bias of both, testing and reporting, to confirm their own biases. Experts are not heard or ignored.
Reading this doesn't really induce panic. I've had worse infections where I did not seek medical help either. I particularily remember an illness roughly two years ago which took 3 weeks to get cured. It was so strong that it fucked with my consciousness for at least a week, time distortions and similar effects.
I feel like I am prepared by life.
I never tried to imply that I feel like I have magical powers.
I just think that overcareful people wouldn't have needed to see a doctor in about 95% of the cases in their life. Granted, there are times when the medical system is really useful to safe your life, but in most cases people just get the reassurance they need, but would have been fine if they just stayed at home without seeing a dctor.
That is my personal opinion, and I have had this opinion since many years. i.e., it is independent of this coronavirus incident.
You think voluntarily trying to ride it out at home instead of using up a hospital bed which could well be used by someone who needs it more urgently is bad behaviour for the herd?
People, you need to stop fighting amongst each other. The panic is killing your sense of logical thinking already.
First, it's about an order of magnitude worse in terms of effects than the flu on average. The "mild" category for Covid-19 includes walking pneunomia which is very much no fun and much more unpleasant than a normal flu, though you can stay at home and ride it out unlike the "severe" or "critical" covid-19 symptoms which require a hospital and oxygen for the severe cases or serious ICU measures for the "critical" cases.
Second, it's a lot more transmissable than the flu and nobody is vaccinated against it. So while flu hospitalizations are going to be spread out across months if we just let Covid-19 run it's course half the population will end up being infected at some particular week. And 10% of people will need hopsitalization. And our hospitals can't cope with anything like that number of people and you'll be seeing a lot more than the default 1% of those infected die.
We really need to take this seriously.
EDIT: I misremembered mild/severe/critical as mild/moderate/severe then corrected it.
